A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Day Surgery Success Rate
研究概览
简要总结
In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2;
- •Conscious, no history of mental illness, accompanied by an adult during the perioperative period;
- •Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;
- •Subjects and families understand perioperative care and are willing and able to complete post-discharge care;
- •Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;
- •According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included.
排除标准
- •Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;
- •Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;
- •Genital tract infection or in the acute phase of systemic infection;
- •Subjects on long-term anticoagulant therapy or with coagulation dysfunction;
- •Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia;
- •A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery;
- •Not willing to undergo endoscopic surgery;
- •Participated in other drug and device clinical trials within 3 months before surgery.
研究组 & 干预措施
Domestic single-port laparoscopic surgery system group
The domestic single-port robotic laparoscopic surgery system is a new minimally invasive surgical method. Compared with traditional laparoscopic surgery, it establishes the surgical approach through the natural scar umbilicus of the human body, thus bringing less trauma and beautiful experience to patients
干预措施: Domestic single-port laparoscopic surgery system (Device)
结局指标
主要结局
Day Surgery Success Rate
时间窗: Patient recruitment ends and all patients complete surgery, up to 2 years
Day surgery success rate means that no other operation is performed during the operation and the patient is discharged within 48 hours.
次要结局
- Abdominal Incision Healing(Within 1 day after surgery)
- Surgeon Satisfaction Evaluation(Up to 1 day after surgery)
- Time of Operation(From pre-surgery to the end of surgery，up to 12 hours)
- Blood Loss Evaluation(From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery)
- Time of First Postoperative Anal Exhaust(Up to 2 day after surgery)
- First Spontaneous Urination Time(Up to 2 day after surgery)
- Pain Score(4 hours after surgery)
- Hospital Stays(From the date of admission to the Date of discharge, assessed up to 2 days)
- Postoperative Rehabilitation Evaluation(Within 1 day after surgery; 24 hours and 30 days after discharge)
- Scar Satisfaction(30 days after discharge)
- Discharge Assessment(Within 1 day after surgery, 4 hours after discharge)
- Postoperative Complication(4 hours, 24 hours and 30 days after discharge)
- Quality and Safety Evaluation of Day Surgery(30 days after discharge)
- Safety Evaluation(Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge)